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RecruitingNCT06301438Updated Feb 3, 2026

Dalpiciclib in HR+/HER2- ABC

An observational study in Advanced Breast Cancer, sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by RenJi Hospital · Observational

From the registry’s dates

  • Started May 2024; still recruiting 2 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
103
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the efficacy and safety of dalpiciclib in patients with HR-positive/HER2-positive advanced breast cancer.

02

Conditions studied

  • Advanced Breast Cancer
03

In context

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer

Inclusion criteria

  • Histologically confirmed advanced breast cancer
  • Hormone receptor-positive and human epidermal growth factor receptor 2-negative
  • ECOG 0-1

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breastfeeding
  • History of immunodeficiency
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
103 participants (estimated)
Patient registry
No

Groups and cohorts

  • dalpiciclib

    dalpiciclib oral day 1-21, every 28 days

    Drug: dalpiciclib

Interventions

  • Drugdalpiciclib

    dalpiciclib oral day 1-21, every 28 days

06

What researchers measure

Primary outcomes

  1. Progression-Free Survival

    The time from the date of starting dalpiciclib to the date of disease progression as per RECIST version 1.1 or death from any cause, whichever occurs first.

    Time frame: From the date of starting dalpiciclib to the date of first documentation of progression or death (up to approximately 1 years)

Secondary outcomes

  1. Adverse events

    Adverse events during dalpiciclib treatment will be assessed according to the NCI CTCAE v5.0.

    Time frame: From the date of starting dalpiciclib to the end of the treatment (up to approximately 1 year)

07

Study locations

1 of 1 sites recruiting
  • Renji Hospital, School of Medicine, Shanghai Jiaotong University
    Shanghai, 200127, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06301438
Lead sponsor
RenJi Hospital
Responsible party
Wenjin Yin (Deputy Chief of Breast Surgery Department, RenJi Hospital) — Principal investigator
First posted
Mar 8, 2024
Start date
May 3, 2024
Primary completion
Jan 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Feb 3, 2026

Study contacts

Wenjin Yin
Contact
yinwenjin@renji.com
86(21)68385569
Wenjin Yin
principal investigator · Renji Hospital, School of Medicine, Shanghai Jiaotong University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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